FDA 483 - Avista Pharma Solutions, Inc. dba Cambrex - May 03, 2024

Avista Pharma Solutions, Inc. dba Cambrex, a control testing laboratory in Longmont, CO, received a Form 483 citing significant deficiencies in its quality control unit, employee training, and laboratory controls. The observations highlight failures in ensuring proper qualification of stability chambers and analytical instruments, maintaining controlled documentation, and providing adequate training for critical defect identification. These issues collectively indicate a lack of adherence to established procedures and robust quality oversight for drug product testing and stability programs.